- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07773519
Effects of a 10-Week High-Intensity Interval Training Programme on Biochemical and Hormonal Responses in Elite Female Futsal Players
19 augusti 2026 uppdaterad av: Shimal Hamza Hamad, Soran University
Temporal Dynamics of Biochemical and Hormonal Responses to Interval Training in Elite Female Futsal Players: A 10-Week Longitudinal Analysis Across Menstrual Cycle Phases
This study aims to investigate the biochemical, hormonal, and physiological adaptations to a 10-week periodized high-intensity interval training (HIIT) programme in elite female futsal players.
The study will examine changes in aerobic fitness, blood lactate kinetics, muscle damage biomarkers, inflammatory markers, and reproductive hormones throughout the intervention.
In addition, the influence of menstrual cycle phases on these physiological responses will be evaluated to improve understanding of sex-specific training adaptations and recovery.
The findings are expected to contribute to evidence-based, individualized training and recovery strategies for female futsal athletes.
Studieöversikt
Status
Avslutad
Detaljerad beskrivning
Female futsal is a high-intensity intermittent team sport requiring substantial aerobic and anaerobic fitness.
Despite increasing participation of women in competitive sports, limited evidence exists regarding the biochemical and hormonal adaptations to structured interval training, particularly across different menstrual cycle phases.
This prospective longitudinal study will recruit 32 elite female futsal players who will participate in a supervised 10-week periodized HIIT programme consisting of lactate threshold training, anaerobic intensification, and sport-specific interval training.
Physiological assessments will include VO₂max, lactate threshold, blood lactate kinetics, creatine kinase, interleukin-6, C-reactive protein, cortisol, and reproductive hormones.
Menstrual cycle phases will be monitored using validated menstrual tracking methods and hormonal confirmation.
Outcomes will be assessed repeatedly throughout the intervention to determine temporal adaptations and the influence of menstrual cycle phase on training responses and recovery.
The results are expected to support individualized, evidence-based training prescription for female athletes.
Studietyp
Interventionell
Inskrivning (Faktisk)
32
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Erbil Governorate
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Soran, Erbil Governorate, Irak, 44008
- Soran Univeristy
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
Inclusion Criteria:
- Female futsal players aged 18-30 years.
- Regular menstrual cycles.
- Participants willing to complete all scheduled testing sessions across the study period.
- Participants able to safely participate in the prescribed physical-performance testing and training programme.
Exclusion Criteria:
- Pregnancy or breastfeeding.
- Irregular menstrual cycles or diagnosed menstrual disorders.
- Use of hormonal contraceptives or hormone therapy within the past 6 months.
- Current musculoskeletal injury or any medical condition affecting physical performance.
- Use of medications known to influence menstrual function, hormonal responses, or physical performance.
- Use of performance-enhancing drugs or medications known to influence hormonal or biochemical responses.
- History of endocrine, cardiovascular, or metabolic disorders.
- Failure to complete all scheduled testing sessions.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Female Futsal Players
Female futsal players will undergo repeated standardized performance testing during different phases of the menstrual cycle.
Assessments include agility, sprint speed, repeated sprint ability, explosive power, balance, and aerobic fitness.
All participants receive the same testing protocol, and no therapeutic intervention is administered.
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Female futsal players will undergo standardized physical performance testing during different phases of the menstrual cycle.
Assessments include agility, sprint speed, repeated sprint ability, explosive power, balance, and aerobic fitness.
The study involves repeated performance assessments only, and no drug, device, surgical procedure, or therapeutic intervention will be administered.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Mean Change from Baseline in Maximum Oxygen Uptake (VO₂max)
Tidsram: Baseline and Week 10
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Maximum oxygen uptake (VO₂max) measured during a graded incremental treadmill exercise test with respiratory gas analysis.
Unit of Measure: mL·kg-¹·min-¹.
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Baseline and Week 10
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Mean Change from Baseline in Velocity at VO₂max (vVO₂max)
Tidsram: Baseline and Week 10
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Velocity at VO₂max (vVO₂max) measured during a graded incremental treadmill exercise test.
Unit of Measure: km/h.
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Baseline and Week 10
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Mean Change from Baseline in Lactate Threshold Velocity
Tidsram: Baseline and Week 10
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Lactate threshold velocity determined during incremental exercise testing.
Lactate threshold velocity is defined as the running velocity corresponding to the lactate threshold.
Unit of measure: km/h.
Higher values indicate improved aerobic endurance.
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Baseline and Week 10
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Mean Change from Baseline in Resting Blood Lactate Concentration
Tidsram: Baseline and Week 10
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Resting blood lactate concentration measured from venous blood samples collected under standardized resting conditions before exercise.
Unit of Measure: mmol/L.
Lower concentrations indicate improved metabolic efficiency.
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Baseline and Week 10
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Mean Change from Baseline in Lactate Clearance Rate
Tidsram: Baseline and Week 10
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Lactate clearance rate calculated as the rate of decline in blood lactate concentration from serial post-exercise measurements obtained during standardized recovery.
The calculated clearance rate is reported as one value in mmol/L/min.
Higher clearance rates indicate improved metabolic recovery.
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Baseline and Week 10
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Serum Creatine Kinase (CK) Concentration at Predefined Recovery Time Points
Tidsram: Baseline; immediately post-exercise; 24 hours; 48 hours; and 72 hours
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Serum creatine kinase concentration measured at baseline and predefined post-exercise recovery time points.
Repeated CK concentrations are evaluated across the predefined sampling time points.
Unit of Measure: U/L.
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Baseline; immediately post-exercise; 24 hours; 48 hours; and 72 hours
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Interleukin-6 (IL-6)
Tidsram: Baseline; immediately post-exercise; and recovery period
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Serum interleukin-6 concentration measured as an indicator of exercise-induced inflammatory response.
Unit of Measure: pg/mL.
Lower resting concentrations and appropriate acute exercise responses indicate improved inflammatory regulation.
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Baseline; immediately post-exercise; and recovery period
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Serum Cortisol
Tidsram: Baseline; menstrual phase-specific assessments; and Week 10
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Serum cortisol concentration measured to evaluate physiological stress responses associated with high-intensity interval training.
Unit of Measure: µg/dL.
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Baseline; menstrual phase-specific assessments; and Week 10
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Serum Estradiol
Tidsram: Phase-specific assessments during the intervention
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Serum estradiol concentration measured to characterize hormonal status during different phases of the menstrual cycle.
Unit of Measure: pg/mL.
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Phase-specific assessments during the intervention
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Serum Progesterone
Tidsram: Phase-specific assessments during the intervention
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Serum progesterone concentration measured to confirm menstrual cycle phase and evaluate hormonal responses during the intervention.
Unit of Measure: ng/mL.
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Phase-specific assessments during the intervention
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Creatine Kinase (CK) Recovery Half-Life
Tidsram: Immediately post-exercise through 72 hours
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Time required for serum creatine kinase concentration to decrease by 50% during the post-exercise recovery period.
Unit of Measure: hours.
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Immediately post-exercise through 72 hours
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Area Under the Concentration-Time Curve of Serum Creatine Kinase (CK)
Tidsram: Immediately post-exercise through 72 hours
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Area under the serum creatine kinase concentration-time curve calculated from serum CK concentrations measured during the post-exercise recovery period.
Unit of Measure: U/L·h.
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Immediately post-exercise through 72 hours
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Buchheit M, Laursen PB. High-intensity interval training, solutions to the programming puzzle: Part I: cardiopulmonary emphasis. Sports Med. 2013 May;43(5):313-38. doi: 10.1007/s40279-013-0029-x.
- Laursen PB, Jenkins DG. The scientific basis for high-intensity interval training: optimising training programmes and maximising performance in highly trained endurance athletes. Sports Med. 2002;32(1):53-73. doi: 10.2165/00007256-200232010-00003.
- Janse de Jonge XA. Effects of the menstrual cycle on exercise performance. Sports Med. 2003;33(11):833-51. doi: 10.2165/00007256-200333110-00004.
- Janse DE Jonge X, Thompson B, Han A. Methodological Recommendations for Menstrual Cycle Research in Sports and Exercise. Med Sci Sports Exerc. 2019 Dec;51(12):2610-2617. doi: 10.1249/MSS.0000000000002073.
- Constantini NW, Dubnov G, Lebrun CM. The menstrual cycle and sport performance. Clin Sports Med. 2005 Apr;24(2):e51-82, xiii-xiv. doi: 10.1016/j.csm.2005.01.003.
- Souglis A, Bourdas DI, Gioldasis A, Ispirlidis I, Philippou A, Zacharakis E, Apostolidis A, Efthymiou G, Travlos AK. Time Course of Performance Indexes, Oxidative Stress, Inflammation, and Muscle Damage Markers after a Female Futsal Match. Sports (Basel). 2023 Jun 29;11(7):127. doi: 10.3390/sports11070127.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
2 februari 2026
Primärt slutförande (Faktisk)
1 juli 2026
Avslutad studie (Faktisk)
1 juli 2026
Studieregistreringsdatum
Först inskickad
31 juli 2026
Först inskickad som uppfyllde QC-kriterierna
14 augusti 2026
Första postat (Faktisk)
19 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- SORANU-HIIT-2026-001
- Ethics Approval Number (Annan identifierare: Soran University Institutional Review Board)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
IPD-planbeskrivning
A decision regarding sharing de-identified individual participant data collected in this study has not yet been finalized.
If data sharing is approved, only de-identified data may be considered for sharing after study completion, subject to institutional policies, ethical requirements, participant confidentiality, and applicable data-protection requirements.
Läkemedels- och apparatinformation, studiedokument
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Nej
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Nej
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